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Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)

This study has been terminated.
(Sponsor terminated due to business reasons)
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Medical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01478087
First received: November 7, 2011
Last updated: February 12, 2013
Last verified: February 2013
Results First Received: January 8, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cardiomyopathy, Dilated
Intervention: Device: Mysorba

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First site open to enrollment : November 3, 2011 Study terminated: March 22, 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three (3) subjects enrolled, 2 completed treatment through six-month follow up. One (1) subject terminated participation prior to treatment due to sponsor stopping the study.

Reporting Groups
  Description
IA Treatment The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.

Participant Flow:   Overall Study
    IA Treatment  
STARTED     3  
COMPLETED     2  
NOT COMPLETED     1  
due to sponsor closing study                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IA Treatment The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.

Baseline Measures
    IA Treatment  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  54.0  ± 6.3  
Gender  
[units: participants]
 
Female     1  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.   [ Time Frame: 30 Days Post Treatment ]

2.  Primary:   Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.   [ Time Frame: 30 days post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jeffrey Lawrence Winters, MD
Organization: Mayo Clinic
phone: 507-538-1707
e-mail: winters.jeffrey@mayo.edu


No publications provided


Responsible Party: Asahi Kasei Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01478087     History of Changes
Other Study ID Numbers: AMA-2011DCM Pilot Study
Study First Received: November 7, 2011
Results First Received: January 8, 2013
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration